Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: CORDIS STEERABLE PTCA BALLOON CATHETER
• Generic Name: Catheters, transluminal coronary angioplasty, percutaneous
• Regulation Number: 870.5100
• Applicant: CORDIS CORP.; P.O. BOX 025700; MIAMI, FL 33102-5700
• PMA Number: P890032
• Date Received: 01/31/1989
• Decision Date: 03/06/1990
• Withdrawal Date: 09/02/2008
• Product Code: LOX
• Docket Number: 90M-0102
• Notice Date: 02/03/1990
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: No
• Combination Product: No
• Supplements: S001 S002 S003 S004 S006 S007 S008 S009 S010 S011 S012 ; S013 S014 S015 S016 S017 S018 S019 S020 S021 S022